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NEWS

Failure to Validate Sunshine Data Accuracy Can Result in Heavy Fines, Consultant Says

Stay ahead of developments in federal and state health care
law, regulation and transactions with timely, expert news and analysis.

July 22 -- Drug and device manufacturers and group purchasing
organizations that fail to validate the accuracy of their spending
data prior to submitting it to the Centers for Medicare & Medicaid
Services' Open Payments program are courting potential fines and
reputational risks, according to a speaker at July 22 webinar.

The CMS can audit data submissions to the Open Payments program at
any time, Jeff Fisher, a manager with Huron Life Sciences, said during
the webinar, and civil monetary penalties (CMPs) for failing to report
data in an accurate and timely fashion can range from $1,000 to
$10,000 per transaction.

CMPs for knowing failures to report data in an accurate and timely
fashion can range from $10,000 to $100,000 per transaction, Fisher
said.

The
Open
Payments program, also known as the Sunshine Act, requires
manufacturers of drugs, devices and other medical supplies and group
purchasing organizations to report certain payments to physicians or
teaching hospitals.

Huron Life Sciences is a unit of Huron Consulting, which is based
in Chicago.

Investigations

In addition to the threat of CMPs, submitted spending data can also
be accessed by the Department of Justice, the Department of Health and
Human Services Office of Inspector General and the Securities and
Exchange Commission, Fisher said, increasing the risk that inaccurate
submissions may prompt government investigations.

The lack of validated Open Payments submissions can lead to the
appearance of kickbacks, reputational damage and the appearance of
inappropriate interactions with health-care providers, Fisher
said.

Under the program, payment data for the past five months of 2013
were due to the CMS June 30, and the data will be available to the
public no later than Sept. 30.

Source System Failures

Fisher said that data submission errors can stem from problems in
three related areas: the source system, the customer master file and
the Open Payments template itself.

Source systems are used by companies to collect their aggregate
spending data, and can occasionally fail to extract full payment data,
he said.

For example, a source system might classify a physician as a
business guest and not extract any payment data surrounding the
transaction.

As for the customer master file, data accuracy is only a good as
what's in the file, he said.

Common errors include misidentifying physicians and the absence of
key identifiers, such as a National Provider Identifier or a state
license number.

Also, the very act of entering spending data into the Open Payments
template can introduce error, Fisher said, due to a failure to fill in
all required fields.

Successful Validation

To eliminate the risk of CMPs and reduce data submission errors,
Fisher said companies should engage in a four-step data validation
process, beginning by analyzing source system data and validating that
the data are accurate.

As a second step, companies should identify the root cause for any
spending data errors and create procedures to correct them. Once
errors have been identified and new procedures created, a third step
should involve implementing the new procedures, Fisher said.

Finally, companies should focus on employee education, ensuring
that employees are cognizant of the root causes behind spending data
errors and aware of the potential consequences for inaccurate data
submissions.

Looking to the future, Fisher said that data analytics surrounding
Open Payments submissions is becoming increasingly sought after.

Data analytics can result in internal data certification,
validation and monitoring, operational insights and risk analysis, he
said.

To facilitate proper data analytics, payment data must be kept in
one place and updated frequently, Fisher said.

To contact the reporter on this story: James Swann in Washington at
jswann1@bna.com

To contact the editor responsible for this story: Ward Pimley at
wpimley@bna.com

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